Quality Control, Microbiology Department – Analyst II / Senior Analyst
- JOINN Bio is looking for highly motivated and determined individuals with expertise in microbiology to join our quality team.
- The successful candidate will perform both Microbiological Testing and Environmental Monitoring of clinical manufacturing process samples.
- Role as either an Analyst II or Senior Analyst will be decided depending on level of experience and qualification
Reporting to Quality Control Management, the Analyst II / Senior Analyst position for the Quality Control Microbiology Department will be responsible for performing microbiological testing and sampling for the Environmental Monitoring program. The Analyst II will play a critical role in implementing, maintaining, and improving JOINN Biological US Inc.'s microbiology department at JOINN Bio's Richmond, CA CDMO manufacturing facility. This position may require off-shift hours including nights and weekend.
Here's What You'll Do:
- Effectively coordinate the execution of the environmental and critical utility monitoring program for the Richmond, CA manufacturing site
- Perform microbiological testing such as Bioburden, Conductivity, TOC, and Endotoxin per USP guidelines
- Collaborate effectively across all departments to meet key objectives
- Conduct technical assessments of deviations and investigations
- Conduct routine trend analysis of environmental monitoring data and prepare associated trend reports
- Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
- Write/revise SOPs, technical protocols and reports
- Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
- Be proactive at keeping current with literature and latest technologies associated with contamination control principals
- Effectively communicate internal issues related to performance, processes, and procedures
- Establish and maintain a safe laboratory working environment
- Accept, complete, and report on special assignments within the agreed upon timeframe
- Act as designee for Quality Control as appropriate
- BS/BA and minimum 5-8 years or MS and 2-5 years in cGMP environment, with a minimum of 2 years in a leadership role (preferred)
- Familiarity with relevant and current FDA, EU, ICH, USP guidelines and regulations
- Strong knowledge of contamination control principals
- Demonstrated knowledge of method development and qualifications
- Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively
- Ability to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
- Excellent communication skills (verbal and written)
- Experience with risk management principals and their application to the development and execution of environmental monitoring and critical utility monitoring programs, preferred
Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefit package.
Job Type: Full Time
Location: Richmond, CA 94806
Work authorization: United States (Required)